MRC kick-off meeting Bess LeRoy and Erin Muhlbradt, MRC co-leads

Agenda What is the MRC and why was it created? Where does the work of this team fit into the overall standards development process? What are the team deliverables? What is the time commitment? How will governance work?

What is the MRC and why was it created? The CDISC Modeling Review Committee (MRC) has been established to provide expert advice and review of modeling issues in CDISC project deliverables, to support quality and consistency of modeling among CDISC standards.

MRC responsibilities Provide early input on technical approaches for new foundational teams and new therapeutic area standards projects, and to identify possible risks and issues.   Review packages of documents/standards prior to internal review to ensure harmonization of modeling with existing standards, including the BRIDG model. Provide advice on the development of CDISC Controlled Terminology to ensure consistent with modeling of other standards. Review modeling issues that have been escalated for resolution from internal CDISC teams or external stakeholders.

Where do we fit in the process? Approved by the MRC Approved by the MRC

What are the team deliverables? Modeling strategy approval  Each team will be asked to complete a modeling strategy worksheet that describes each concept, domain placement, and a general modeling strategy for that concept. They will also be asked to identify any potential road blocks that might need detailed discussion such as new domains, variables, or modeling that may be controversial (e.g., combination therapy, pre-specified findings, etc.). This will ensure that the team is on the right track from the beginning. 

What are the team deliverables? Consultation  A team can sign up to get technical advice on concept maps as well as CDASH, SDTM, and ADaM examples. Submitters need to upload their concept map or proposal to the sign-up sheet. 

What are the team deliverables? Example approval  Review of the final examples that have been developed prior to internal review to make sure that they are consistent with the decisions that have been made based on the approved modeling strategy and previous consultations.

What is the time commitment? A few hours a week plus the weekly meeting We are creating the standards that will be used by our community. Appropriate vetting early on will lead to a better product.

How will governance work? All active CDISC team members are welcome to participate! The MRC will have rotating voting members within the team to ensure that draft standards are appropriately vetted before moving to the next stage of development. The voting members will be composed of representatives from the following teams: SDS CDASH ADaM CFAST Controlled Terminology Decision making process What constitutes a quorum? Who can vote on which topics?  Length of voting term?